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DTSTART:20190331T010000
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DTSTART;VALUE=DATE:20190213
DTEND;VALUE=DATE:20190216
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SUMMARY:Introductory Course in Exploratory Medicines Development – Part I
DESCRIPTION:This course addresses postgraduates in life sciences interested in early clinical development of medicinal products. Two training parts of several days provide a concise overview on Human Pharmacology / Translational Medicine spanning from non-clinical pharmacology and toxicology over first-in-man studies to proof-of-concept clinical trials. \nThis AGAH course meets the standards for high-quality postgraduate education and training in Medicines Development established by PharmaTrain and has been awarded a PharmaTrain Recognition. The course (Parts I plus II) was accredited 3 ECTS. \n\n\n\n	 \nIntroduction and Learning Outcomes \n \nThis course addresses postgraduates in life sciences interested in early clinical development of medicinal products. Two training parts of several days provide a concise overview on Human Pharmacology / Translational Medicine spanning from non-clinical pharmacology and toxicology over first-in-man studies to proof-of-concept clinical trials. \nLearning Outcomes \nOn successful completion of Part 1\, students should be able to demonstrate an understanding / knowledge of the following: \n\nprincipal steps in drug development – from compound selection to marketing application and beyond\npertinent issues involved in the undertaking of early clinical research\nspecific aspects of how to set-up and conduct early phase clinical trials\nregulation of medicines in Europe\ndevelopment and review of compound-specific information to ensure adherence to scientific\, medical\, ethical\, and legal provisions\nintegration of pertinent available scientific information into an IB and a clinical trial protocol\nprinciples of trial design\, protocol submission and clinical conduct\nselection of appropriate trial population\nmost common early phase clinical trials and their specific requirements\nassessment and evaluation of safety data from clinical trials\nrelevance of formulation properties and in vitro characteristics of the trial medication for design and planning of an early phase clinical trial\nbasics of pharmacokinetics\ndefining pharmacokinetic (PK) endpoints for early phase clinical trials\nmethod validation according to good clinical (GCP) and good laboratory (GLP) practise practical aspects of bioequivalence trials\n\nThis AGAH course meets the standards for high-quality postgraduate education and training in Medicines Development established by PharmaTrain and has been awarded a PharmaTrain Recognition. The course (in 2016/17) was accredited 3 ECTS (Parts I plus II). \n\n\n\n\n	 \nDay 1: Wednesday\, 13th February 2019 \n \n09:00 – 09:30 \nIntroduction of faculty and participants \n\n09:30 – 10:30 \nOverview on the drug development process:Nonclinical studies\, evaluation of toxicity\, pharmacokinetics\, pharmacodynamics\, First-in-human\, Phases I to III\, exploratory vs. confirmatory trials\, submission and marketing authorisation; Phase IV\, non-interventional studies / post-marketing surveillance\, epidemiological studies; go/no-go decision making\, definition of proof-of-mechanism (PoM)\, proof-of-concept (PoC) \nGeorg Wensing  \n\n10:30 – 10:45 \nBreak \n\n10:45 – 12:00 \nDesign elements of human pharmacology trials: Controlled / uncontrolled\, placebo / active control\, cross-over / parallel-group\, single-blind / double-blind\, single dose / multiple dose\, randomisation procedures\, dose-escalation\, staggered timing\, combined protocols\, adaptive elements\, microdosing studies \nWolfgang Timmer \n\n12:00 – 12:45\nRegulatory and ethical aspects of trial conduct I: Risk-benefit evaluation\, GCP\, Declaration of Helsinki\, EU-Directive and Regulation\, ICH-Guidelines \nKerstin Breithaupt-Grögler \n\n12:45 – 13:45 \nBreak \n\n13:45 – 14:30\nRegulatory and ethical aspects of trial conduct II: Trial authorisation: ethics committee favourable opinion and competent authority approval \nKerstin Breithaupt-Grögler \n\n14:45 – 15:00 \nBreak \n\n15:00 – 16:30\nMost common early phase clinical trials: First-in-human\, safety\, exploratory PK and PD\, drug-drug-interaction\, drug-food interaction\, bioavailability / bioequivalence\, QTc trials\, PoC trials \nWolfgang Timmer \n\n16:30 – 17:00\nFirst-in-human trials in patients: most common designs for dose escalation\, relevant differences vs trials in healthy subjects \nAntje Blank \n\n17:00 – 17:15 \nBreak \n\n17:15 – 18:00 \nTrial protocol and investigator's brochure: How to integrate information from scientific literature\, nonclinical / clinical information and other sources; primary and secondary objectives vs. endpoints\, differences between IB and IMPD \nKerstin Breithaupt-Grögler \n\n18:30 – 20:30 \n  \nGet together: formation of break-out groups \n\n\n\n\n	 \nDay 2: Thursday\, 14th February 2019\n \n  \n08:45 – 10:30 \nConduct of clinical trials (including case study): Safety parameters and stopping criteria (AE\, SAE\, ADR\, SUSAR)\, relationship to trial medication\, severity of AE\, liver / renal toxicity\, general tolerability\, local tolerance\, monitoring of vital signs \nAntje Blank  \n\n10:30 – 10:45 \nBreak \n\n10:45 – 12:00 \nConduct of clinical trials (including case study): Practical aspects in planning of early phase trials \nSybille Baumann  \n\n12:00 – 13:00 \nBreak \n\n13:00 – 14:30 \nSelection of trial population and definition of inclusion / exclusion criteria in early drug development (including case study): Healthy subjects\, symptomatic subjects\, patients in early phase\, children\, elderly\, gender\, ethnicities\, cultural differences \nKatharina Erb-Zohar \n\n14:30 – 15:00 \nConduct of clinical trials: Site selection\nKatharina Erb-Zohar \n\n15:00 – 15:15 \nBreak \n\n15:15 – 15:45 \nConduct of clinical trials: Independent data monitoring committee \nKatharina Erb-Zohar \n\n15:45 – 16:30 \nConduct of clinical trials: Subject / patient informed consent in early phase clinical trials \nKerstin Breithaupt-Grögler  \n\n16:30 – 16:45 \nBreak \n\n16:45 – 18:15 \nTrial medication: drug substance / product\, labelling\, stability\, drug accountability\, code breaking envelopes / emergency unblinding\, specific aspects of preparation / administration / storage in Phase I\, route of administration\, formulations\, fasted or fed conditions\, blinding\, double-dummy\, test / reference therapy\, challenging substances\, IMPD information\, non-IMPD medication\, release process according to ANNEX 1 \nAndré Warnke \n\n\n\n\n	 \nDay 3: Friday\, 15th February 2019\n \n  \n08:45 – 09:00 \nDiscussion of homework: case studies: AE/SAE documentation\, set-up of a FIH / a BE trial \nKerstin Breithaupt-Grögler \n\n09:00 – 10:30 \nPharmacokinetics I: ADME\, drug-drug interaction\, drug-food interaction\, bioequivalence / bioavailability\, steady state\, accumulation factors \nAndreas Kovar \n\n10:30 – 10:45 \nBreak \n\n10:45 – 13:00 \nPharmacokinetics II: pharmacogenetics / polymorphisms\, pharmacometrics\, PK/PD relationship \nAndreas Kovar \n\n13:00 – 13:45 \nBreak \n\n13:45 – 14:45 \nGCP / GLP – focus on method validation: Bioanalytics\, sample collection\, sample preparation\, quality assurance procedures \nAndré Warnke \n  \n\n14:00 – 14:15 \nBreak \n\n14:15 – 16:00 \nHow to proceed from single ascending dose to multiple ascending dose? Assessment and evaluation of SAD safety and PK data\, integrated protocols versus consecutive trials\nKarin Göhler \n\n14:45 – 15.00 \nBreak \n\n15:00 – 16:00 \nBioequivalence trials: How to do it right – planning a successful BE trial \nAndré Warnke \n\n16:00 – 16.45 \nMandatory Test on Part I (50% of questions must be correctly answered to pass test and receive a certificate) \nKerstin Breithaupt-Grögler    \n\n16:45 – 17:00 \nFeed back and end of Part I \n\n\n\n\n	 \nAttendance Fees\n \n\n\n\n1.100 €\n1.450 €\nMembers of the AGAH\, AHPPI\, BAPU\, Club Phase I\, EUFEMED\nNon-Members\n\n\n1.900 € \n2.500 € \n\nPart I plus II\nfor Members of the AGAH\, AHPPI\, BAPU\, Club Phase I\, EUFEMED \nPart I plus II for Non-Members \n\n\n\n\nSpecial fees for students are available on request \n\n\n\n\n	 \nVenue\n \nSocraTec R&D GmbH\nIm Setzling 35\n61440 Oberursel \n\n\n\n\n	 \nContact and further information\n \nAssociation for Applied Human Pharmacology (AGAH) e. V.\noffice: Goernestraße 30\n20249 Hamburg \nphone: +49 40 30772097\ne-Mail: info ( a t ) agah.eu\nWeb:   www.agah.eu \n\n\n\n\n	 \nDownloads\n \nAGAH_Programme_ICiEM2019_PartI \nAGAH_ICiEM_Registration_form
URL:https://dev.agah.eu/event/introductory-course-in-exploratory-medicines-development-part-i-2/
LOCATION:AGAH Workshop\, Oberursel\, Deutschland
CATEGORIES:Workshops
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